PureWick™ France and U.S. At-Home Pilot Study

NACompletedINTERVENTIONAL
Enrollment

17

Participants

Timeline

Start Date

October 31, 2023

Primary Completion Date

August 25, 2024

Study Completion Date

August 25, 2024

Conditions
Nocturnal Enuresis
Interventions
DEVICE

PureWick™ System

The PureWick™ FEC is intended for non-invasive urine output management in female patients. The PureWick™ FEC is a flexible, contoured external catheter that is positioned against the area where urine exits the female body. The PureWick™ FEC is connected to the PureWick™ Urine Collection System (PUCS) via connector tubing. The PUCS uses suction (not felt by the user) to pull voided urine through the device, regardless of the urine flow rate. Urine continues through vinyl tubing until it reaches a collection canister, away from the body.

DEVICE

Hollister® Female Urinary Pouch External Collection Device

The Hollister Female Urinary Pouch External Collection Device is intended to collect and contain urine for individuals with urinary incontinence. It is designed to be emptied and should be attached to a drainage bag. The FUP is made with hydrocolloid skin adhesive and polymer/copolymer plastics.

Trial Locations (2)

10065

Weill Cornell Medical Center, New York

30338

Smiths Medical Center, Dunwoody

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Becton, Dickinson and Company

INDUSTRY

lead

C. R. Bard

INDUSTRY